RemB Electric Universal Driver Instructions for Use Rev C Oct 2012

RemB Electric Universal Driver ®

6400-099-000

Instructions For Use

ENGLISH (EN) 2012-10

6400-099-700 Rev-C

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EN

6400-099-700 Rev-C

Introduction This Instructions For Use manual is the most comprehensive source of information for the safe and effective use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information. For additional information, especially safety information, or inservice training, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. NOTE: The RemB Electric Universal Driver (handpiece) is also known as the RemB Universal Driver.

Indications For Use The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORETM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue, including the spine. This includes but is not limited to Orthopedic, Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM). NOTE: The RemB Electric Universal Driver must meet the following console compatibility requirements: TPS software version 4.x and higher, CORE software version 5.7 and higher.

Contraindications None known.

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User/Patient Safety WARNINGS: • Only trained and experienced healthcare professionals should use this equipment. • Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique for each patient. Stryker, as a manufacturer, does not recommend surgical technique. • ALWAYS allow the equipment to reach the specified operation temperature range before use. See the Specifications section. • Upon initial receipt and before each use, clean and sterilize the equipment as indicated. See the RemB Electric Cleaning, Maintenance and Sterilization Recommendations for care instructions. • Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See the RemB Electric Cleaning, Maintenance and Sterilization Recommendations for inspection criteria. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or nitrous oxide.

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Accessories WARNINGS: • Use only Stryker-approved system components and accessories unless otherwise specified. • DO NOT modify any component or accessory unless otherwise specified. • DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a single use only. A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. Design features may make cleaning difficult. Reuse may create a serious risk of contamination and may compromise the structural integrity of the single use device resulting in operational failure. Critical product information may be lost if the single use device is repackaged. Failure to comply may lead to infection or crossinfection and result in patient and/or healthcare staff injury. • All cutting accessories are intended for single use only. Reuse significantly increases wear on the handpiece and attachment. • Wobbling may cause inaccurate wire or pin placement and/or bone or tissue damage. If wobbling occurs, see Troubleshooting. • When using the Universal Driver, always use Stryker attachments with two J-slots. The Universal Driver will not fully retain Stryker attachments with only one J-slot.

Use attachments with two J-slots.

DO NOT use earlier versions of the Stryker Wire Collet (REF 4100-062-000) or Pin Collet (REF 4100-125-000). Both collets have only one J-slot.

A variety of specialized attachments are available for use with the handpiece. Each attachment has a specialized retainer for wires, pins, tools or cutting accessories. See the Cordless Driver and Universal Driver Attachments Instructions For Use for specific attachment and accessory instructions. NOTE: For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. The following Stryker-approved accessories are sold separately:

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DESCRIPTION

REF

Handpiece Cord

5100-004-000

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Features Handpiece A B C

D

E F

H

G A

Release Button – Press to release an attachment from the handpiece.

B

Attachment Connector

C

Applied Part – The distal end of the handpiece and the attachment (as defined by the Product Safety Certification standards listed in the Specifications section of the instructions for use supplied with the console.)

D

Attachment

E

Reverse Trigger – Press this pressure sensitive trigger to obtain variable speed reverse operation.

F

Forward Trigger – Press this pressure sensitive trigger to obtain variable speed forward operation.

G

Cord Receptacle

H

Function Switch – Adjust this switch to the desired function. Functions and switch positions are described below.

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Features (continued) Function Switch SAFETY – Fully depress the switch to lock both triggers.

FORWARD – Center the switch to lock the reverse trigger. The forward trigger is functional. FORWARD/REVERSE – Fully extend the switch to unlock both triggers. Both triggers are functional.

Definitions The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment. SYMBOL

DEFINITION REVERSE TRIGGER FORWARD TRIGGER SAFETY

FORWARD

FORWARD/REVERSE Cord Alignment Mark Consult instructions for use

General warning sign

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Instructions WARNINGS: • DO NOT attempt to insert or remove any cutting accessory or attachment while the handpiece is operating. • Follow the recommended duty cycle to prevent the components from overheating. See Specifications. • Before operating the handpiece, gently tug the attachment to verify the attachment is secure. • ALWAYS set the function switch to the SAFETY position while the handpiece is idle, when passing the handpiece to another person, or before inserting or removing a cutting accessory or attachment. • DO NOT press the pedal of a connected footswitch while the function switch is set to the SAFETY position. An accidental pedal press will override the SAFETY position and activate the handpiece. CAUTION: During an endoscopic procedure, DO NOT introduce the handpiece through the same orifice as the endoscope. NOTE: See the Cordless Driver and Universal Driver Attachments Instructions For Use for specific attachment and accessory instructions.

To Install an Attachment 1. Vertically align the two J-slots on the attachment with the attachment connector. 2. Insert the attachment into the attachment connector until it snaps into place.

3. Gently tug the attachment to verify the attachment is secure.

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Instructions (continued) To Operate the Handpiece NOTE: See the instructions for use supplied with the appropriate console for additional information about handpiece operation. 1. Install an accessory into the attachment. NOTE: See the instructions for use supplied with the attachment to properly install an appropriate accessory. 2. Plug one end of the cord into the handpiece cord receptacle and the other end of the cord into the appropriate console cord receptacle. 3. Use the console to program the operational settings of the handpiece as required. NOTES: • When using the console, the Forward and Reverse buttons on the Universal Driver Screen do not function. Use the handpiece triggers or a footswitch to select the handpiece direction. • When using the console, the Oscillate button will initiate a turn-based oscillate mode that defaults to a one-turn oscillation. Use the console touchscreen to select more turns as required. • Depress both triggers together to operate the handpiece in the oscillate mode. • Pressure on a trigger will also control the speed of the handpiece. 4. Use either the handpiece triggers or a footswitch to operate the handpiece. NOTE: Use the console touchscreen to assign different functions (such as the oscillate mode) to the footswitch pedals as required.

To Remove an Attachment 1. Fully depress the release button. 2. Firmly grasp and pull the attachment from the attachment connector.

Final Disassembly 1. Unplug the cord from the console and from the handpiece. 2. Remove attachment as described above.

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Troubleshooting WARNING: DO NOT disassemble or service this equipment unless otherwise specified. NOTE: For service, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. PROBLEM

CAUSE

ACTION

The console fails to recognize the handpiece or displays a handpiece error message.

The console software is not compatible with the handpiece.

Contact Stryker to obtain console upgrade information.

An electrical malfunction exists.

Return the handpiece for repair.

The handpiece will not operate.

The function switch is in the SAFETY position.

Set the function switch to the FORWARD or FORWARD/ REVERSE position.

An electrical malfunction exists.

Return the handpiece for repair.

The handpiece operation is rough or slow.

An electrical malfunction exists.

Return the handpiece for repair.

The attachment wobbles.

The wire or pin extends too far from the distal end of the handpiece, is the wrong size, or is not properly centered in the attachment.

Reinsert the wire or pin. If the attachment continues to wobble, return the handpiece for repair.

The pin slips in Pin Collet (REF 4100125-000).

Design limitations exist.

Use Pin Collet (REF 4100-126-000).

The function switch does not operate as expected.

The switch position symbols were not used to set the function switch.

Look at the switch position symbols on the side of the handpiece to properly set the function switch.

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Troubleshooting (continued) PROBLEM

CAUSE

ACTION

The attachment is difficult to install and/or interference is experienced during installation.

The release button mechanism needs lubrication.

See the care instructions supplied with the handpiece.

Sporadic electrical interference is experienced.

Electrical noise is present.

Turn off all electrical equipment not in use in the operating room. Relocate electrical equipment; increase spatial distance. Plug operating room equipment into different operating room outlets.

Cleaning See the care instructions manual supplied with the equipment.

Inspection and Testing See the care instructions manual supplied with the equipment. NOTE: Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only.

Sterilization See the care instructions manual supplied with the equipment.

Storage and Handling CAUTION: ALWAYS store the equipment within the specified environmental condition values throughout its useful life. See the Specifications section. To ensure the longevity, performance and safety of this equipment, use of the original packaging material is recommended when storing or transporting this equipment.

Disposal/Recycle WARNING: Follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the equipment at the end of its useful life. 10

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Specifications WARNING: ALWAYS check any documentation that accompanies attachments and/or cutting accessories for special duty cycle and usage instructions. Model:

RemB Electric Universal Driver REF 6400-099-000

Dimensions:

5.3 inch [136 mm] height 1.02 inch [26 mm] width 5.47 inch [139 mm] length

Mass:

1.04 lb [0.47 kg]

Speed:

1,500 rpm

Mode of Operation: Duty Cycle: Rest Between Cycles:

Non-continuous Operation 20 seconds on/20 seconds off, 6 times 45 minutes

Power Supply:

Stryker CORE or TPS Console 40 V (Direct Current)

Equipment Type: Type BF Applied Part Maximum Temperature of Applied Part:

Less than 124 °F [51 °C] (Maximum surface temperature as tested to the standards listed under Product Safety Certification in the instructions for use supplied with the console.)

Ingress Protection:

IPX0 Ordinary Equipment

Environmental Conditions:

Operation

Storage and Transportation

Temperature Limitation: Humidity Limitation:

Atmospheric Pressure Limitation:

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ES/DE/FR/IT/NL JA/ZH/KO SV/DA/FI/PT/NO PL/EL

6400-099-713 6400-099-720 6400-099-730 6400-099-750

Stryker Instruments 4100 E. Milham Kalamazoo, Michigan (USA) 49001 1-269-323-7700 1-800-253-3210

Stryker France ZAC Satolas Green Pusignan Av. de Satolas Green 69881 MEYZIEU Cedex France 2012-10

6400-099-700 Rev-C

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